Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer

NCT07366528 | Recruiting Phase 3

• 1 other identifier: DRAGON-Adjuvant/2025-No.675
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.

Conditions

Gastric Cancer (GC); Adjuvant Chemotherapy; Stage 3 Cancer; Docetaxel; Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival rate

  Defined as the proportion of patients who remain free from recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause at 3 years after randomization.

  From randomization to 3 years after randomization

Secondary Outcomes (3)

• 5-year overall survival rate

  From randomization to 5 years after randomization

• Safety profiles

  through treatment completion, an average of 6 months

• Recurrence sites

  From randomization to 3 years after randomization

Study Arms (2)

Oxaliplatin plus S-1

EXPERIMENTAL

Patients will be treated with oxaliplatin plus S-1 as adjuvant therapy

Drug: Oxaliplatin plus S-1

Docetaxel plus S-1

ACTIVE COMPARATOR

Patients will be treated with docetaxel plus S-1 as adjuvant therapy

Drug: Docetaxel plus S-1

Interventions

Oxaliplatin plus S-1 DRUG

SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (\<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; \>1.5m2 60mg twice a day, days 1 to 14 of each cycle).

Oxaliplatin plus S-1

Docetaxel plus S-1 DRUG

DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.

Docetaxel plus S-1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 to 80 years old, male and female
• histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
• patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy
• American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b, T4aN3b, T4bN3a, T4bN3b), and has Lauren classification
• with no evidence of metastatic disease
• ECOG 0 to 1
• Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
• Woman of childbearing age should contracept for at least one month before screening and commit to using contraception throughout the entire study period and for the specified time after the study ends.
• Signed informed consent and willing to follow the study protocol

You may not qualify if:

• other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
• severe complications that may lead to an expected survival time less than 5 years
• uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases.
• allergic to study medication
• bowel obstruction or other conditions affecting oral administration
• organ functions that cannot tolerate study treatment
• other conditions that patients are unsuitable for this study assessed by the investigators

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (5)

Yuebei People's Hospital

Shaoguan, Guandong, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

NOT YET RECRUITING

Renji Hospital

Shanghai, China

NOT YET RECRUITING

Ruijin Hospital

Shanghai, China

RECRUITING

Shanghai Tenth People's Hospital

Shanghai, China

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasms

Interventions

Oxaliplatin; S 1 (combination); Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Central Study Contacts

Chenfei Zhou, MD, Ph.D

CONTACT

+86-21-64370045; zcf12085@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (\<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; \>1.5m2 60mg twice a day, days 1 to 14 of each cycle). DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 31, 2030
• Last Updated: January 26, 2026

Record last verified: 2025-10

Locations

CN (5)